CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

February 16, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Vyxeos

Fixed dose of Vyxeos (44 mg/m2 daunorubicin and 100 mg/m2 cytarabine) (Day 1, 3, and 5) in combination with various dose schedules of Gemtuzumab Ozogamicin (GO)

DRUG

Gemtuzumab Ozogamicin

"Participants will be treated at the following dose levels:~Dose Level 1 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1 Dose Level 2 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1 and 4 Dose Level 3 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1, 4, 7"

Trial Locations (1)

33612

RECRUITING

Moffitt Cancer Center, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER